Friday, July 22, 2011Last Update: 5:22 AM PT

Surgeon Accused of Implanting Unnecessary Pacemakers for Profit

SANTA FE, N.M. (CN) - A cardiac surgeon is accused of intentionally misdiagnosing nearly a dozen patients to trick them into undergoing expensive pacemaker surgery. The 11 plaintiffs, two of them suing for an estate, also accused the manufacturer of the pacemakers of impeding investigation. Nine former patients and representatives of two deceased former patients sued Dr. Demosthenes Klonis and the medical practice where he worked, in Santa Fe County Court. The patients claim Klonis intentionally misdiagnosed minor heart dysrhythmias and nonexistent conditions in order to recommend implantation of expensive pacemakers. They claim Klonis prescribed beta-blockers and other medication to alter the heart rate and then used those changes in heart rate to justify his diagnoses. Klonis began working at co-defendant Mountain View Regional Medical Center in 2005, according to the complaint. Between April 2006 and May 2007, the small Las Cruces hospital did more then 25 percent of all pacemaker implantations in New Mexico, and Klonis did most of those surgeries, the plaintiffs say. They say Klonis' 120-bed hospital performed more pacemaker surgeries than the largest cardiac care medical group in the state - more than the Presbyterian Hospital or the University of New Mexico Hospital in Albuquerque, each of which is hospitals is more than four times larger than the Mountain View Hospital. The plaintiffs also sued New Mexico Cardiology and Arrhythmia Consultants, and White Sands Institute for Clinical Research, for both of which Klonis is the sole director, shareholder, officer and agent. From 2006 to 2010, plaintiffs say, Klonis exclusively implanted pacemakers made by Biotronik, also a defendant. "Dr. Klonis implanted about 100 Biotronik devices into patients' bodies each year during this 4-year period of times," the complaint states. During the same period, Biotronik's Southern New Mexico field representative Edward Tague "assisted defendant Klonis in his invasive procedures cardiac practice continuously and on a full-time basis," according to the complaint. "This included going with Dr. Klonis to the MVH cardiac catheterization laboratory to implant Biotronik pacemakers into patients' chests, and going to Klonis' private office every day to do 'interrogation' and reprogramming procedures on Biotronik pacemakers that had already been implanted into patients' chests. Dr. Klonis has testified that from 2006 through 2010, there was at least one Biotronik device 'interrogation' procedure done at his office every day." Tague is not named as a defendant. The plaintiffs say that it would have cost Klonis $50,000 a year to pay a nurse or technician to do these "interrogations." But "Biotronik, through its representative Mr. Tague, provided this valuable service to defendant Klonis absolutely free of charge over a period of 4 years. Defendant Biotronik paid Mr. Tague well to assist Dr. Klonis on a full-time basis. In 2009 Biotronik paid Tague of 290 thousand dollars ($290,000)." Plaintiffs add: "Tague has testified that in or about 2009 he was selling 8 to 12 Biotronik pacemakers a month in Southern New Mexico, and that 95 percent of these sales in Southern New Mexico came from defendant Klonis placing orders for his patients (who include the 10 plaintiffs in this case). Biotronik was selling pacemakers for approximately six thousand dollars ($6,000) each." (Parentheses in complaint.) The complaint then cites two Page 1 articles from The New York Times. On April 1 this year, the Times reported that the Justice Department was investigating Biotronik's marketing and sales practices. "The investigation involves allegations of hiring doctors as consultants and making improper payments to doctors in order to bolster sales," according to the complaint. On May 31, the Times reported "that Biotronik might be hiring cardiologists to help Biotronik do clinical trial research 'to help them [cardiologists] generate income from research fees.' The U.S. Justice Department has been concerned about 'the role of corporate influence over medicine like bogus or inflated consulting deals with doctors.' According to defendant Klonis, he has been paid by defendant Biotronik to teach, consult, and to do research." (Brackets in complaint.) The plaintiffs say that Biotronik provided two "pacemaker programmers" for Tague and Klonis, at Klonis' office, starting in 2006. "In August 2008,9 [sic] according to Biotronik representative Tague, one of the Biotronik programmers 'crashed' such that information stored in the programmer's memory could not be accessed. The interrogation information for every patient of Dr. Klonis who had a Biotronik device - hundreds of patients - was on that programmer," according to the complaint. In a footnote, the complaint adds: "To date defendants Klonis and Biotronik have refused to say what happened to the second Biotronik programmer computer. Indeed, defendants have refused even to acknowledge the presence of two programmers - that information has come from third-party witnesses who are not parties to this litigation." The plaintiffs claim that the crashed programmer was sent to Biotronik International headquarters in Berlin, Germany, where a technician replaced its central circuit board, which, according to Biotronik, "'erased any electronic information that was stored on the computer programmer,' which is to say that the heart pacemaker interrogation medical records of hundreds of patients in Las Cruces, New Mexico, had been erased." Because of this data loss, there is no record of the post-operative heart rhythms and heart health of the patients to place into evidence, the plaintiffs say. They add: "Plaintiffs' investigation into their cases is very early. Plaintiffs are concerned that the nonavailability or even destruction of records may be ongoing and that it is necessary to institute their complaints early, rather than run the risk of losing legal rights by any delay in filing of their claims." Plaintiffs seek punitive damages for medical negligence, unfair trade, civil conspiracy and prima facie tort. They are represented by Corbin Hildebrandt and James Bromberg. Bromberg is an M.D. and a lawyer.